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Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT03363750
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
The Center for Mind-Body Medicine
Eskenazi Health
Information provided by (Responsible Party):
Michelle Salyers, Indiana University

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Change in Children's Depression Inventory-2 (CDI-2) scores [ Time Frame: from baseline to within one month after end of intervention ]
    self report long version (28 items) to assess the presence and severity of depressive symptoms in children
  • Change in Children's Depression Inventory-2 (CDI-2) scores [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report long version (28 items) to assess the presence and severity of depressive symptoms in children
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03363750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Change in Patient Health Questionnaire-9 (PHQ-9) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (9 questions) to screen for the presence and severity of depression
  • Change in Patient Health Questionnaire-9 (PHQ-9) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (9 questions) to screen for the presence and severity of depression
  • Change in Rumination Subscale of the Children's Response Style Questionnaire Score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (13 questions) of rumination symptoms
  • Change in Rumination Subscale of the Children's Response Style Questionnaire Score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (13 questions) of rumination symptoms
  • Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
  • Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
  • Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
  • Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
  • Change in Suicide Ideation Questionnaire (SIQ) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
  • Change in Suicide Ideation Questionnaire (SIQ) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
  • Acceptability Questionnaire [ Time Frame: within one month after end of intervention ]
    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
  • Acceptability Questionnaire [ Time Frame: approximately 3 months after end of intervention ]
    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
  • Acceptability Questionnaire - open-ended questions for qualitative analyses [ Time Frame: within one month after end of intervention ]
    3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
  • Acceptability Questionnaire - open-ended questions for qualitative analyses [ Time Frame: approximately 3 months after end of intervention ]
    3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
  • Change in Hope Scale Score [ Time Frame: from baseline to within one month after end of intervention ]
    • self report (12 items), 4-point Likert scale(1=Definitely False to 4=Definitely True)
    • evaluates global hope (range 8-32); there are also 2 subscales: hope agency (range 4-16) and hope pathways (range 4-16)
    • includes distracter items
    • global hope score calculated by summing the hope agency and hope pathways scores (omitting distracter items)
    • higher scores indicate a person has higher hope
  • Change in Hope Scale Score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    • self report (12 items), 4-point Likert scale(1=Definitely False to 4=Definitely True)
    • evaluates global hope (range 8-32); there are also 2 subscales: hope agency (range 4-16) and hope pathways (range 4-16)
    • includes distracter items
    • global hope score calculated by summing the hope agency and hope pathways scores (omitting distracter items)
    • higher scores indicate a person has higher hope
  • Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score [ Time Frame: from baseline to within one month after end of intervention ]
    • self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning
    • 5-point Likert scale (1=none of the time to 5=all of the time)
    • total score is calculated by summing each item score (range 14-70)
    • higher scores represent increased levels of mental wellbeing
  • Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    • self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning (range 14-70)
    • 5-point Likert scale (1=none of the time to 5=all of the time)
    • total score is calculated by summing each item score (range 14-70)
    • higher scores represent increased levels of mental wellbeing
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Change in Patient Health Questionnaire-9 (PHQ-9) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (9 questions) to screen for the presence and severity of depression
  • Change in Patient Health Questionnaire-9 (PHQ-9) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (9 questions) to screen for the presence and severity of depression
  • Change in Rumination Subscale of the Children's Response Style Questionnaire Score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (13 questions) of rumination symptoms
  • Change in Rumination Subscale of the Children's Response Style Questionnaire Score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (13 questions) of rumination symptoms
  • Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
  • Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present
  • Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
  • Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms
  • Change in Suicide Ideation Questionnaire (SIQ) score [ Time Frame: from baseline to within one month after end of intervention ]
    self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
  • Change in Suicide Ideation Questionnaire (SIQ) score [ Time Frame: from baseline to approximately 3 months after end of intervention ]
    self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation
  • Acceptability Questionnaire [ Time Frame: within one month after end of intervention ]
    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
  • Acceptability Questionnaire [ Time Frame: approximately 3 months after end of intervention ]
    self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention
  • Acceptability Questionnaire - open-ended questions for qualitative analyses [ Time Frame: within one month after end of intervention ]
    3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
  • Acceptability Questionnaire - open-ended questions for qualitative analyses [ Time Frame: approximately 3 months after end of intervention ]
    3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Official Title  ICMJE Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Brief Summary The Center for Mind -Body Medicine has developed a mind-body skills group program that incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement. These mind-body skills are designed to increase self-awareness and self-regulation. This program has been shown to significantly improve depression symptoms in children and adolescents with posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent population. The purpose of this study is to determine the feasibility of using mind-body skills groups to reduce depression in adolescents and to investigate the effects of the program on factors such as self-efficacy, mindfulness and rumination which are likely to mediate improvement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Depression
  • Depressive Disorder
Intervention  ICMJE Behavioral: mind-body-skills group
mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement
Study Arms  ICMJE Experimental: mind-body-skills intervention
mind-body-skills group intervention offered weekly for 10 weeks
Intervention: Behavioral: mind-body-skills group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)		 75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eskenazi Primary Care patients at time of screening
  • 13-17 years old
  • Diagnosis of depression confirmed by Mini International Neuropsychiatric Interview (MINI) Kid Screen (with adolescent)
  • English speaking
  • Willingness to attend mind body skills group for duration of the intervention (10 sessions over approximately 10 weeks)

Exclusion Criteria:

  • History of bipolar disorder or psychosis
  • Acute and immediate risk of suicide, determined by clinical assessment
  • Lack of capacity to assent (adolescent) or lack of capacity to consent (parent/guardian)
  • Previous participation by the adolescent in the Eskenazi Mind Body Group intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer M Garabrant 317-278-2510 jwilkers@iu.edu
Contact: Lindsey D Jones 317-278-5636 ldj2@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363750
Other Study ID Numbers  ICMJE 1707293729
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michelle Salyers, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • The Center for Mind-Body Medicine
  • Eskenazi Health
Investigators  ICMJE
Principal Investigator: Michelle P Salyers, PhD Indiana University
PRS Account Indiana University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP